drugset / Trial / NCT05158699
Effectiveness of Periocular Drug Injection in CATaract Surgery
Phase 3
Terminated
628 enrolled
Luigi Rondas
European Society of Cataract and Refractive Surgeons · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Cystoid macular edema (CME) is a major cause of suboptimal postoperative visual acuity after cataract surgery. Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent CME. However, noncompliance with eye drops may compromise the effectiveness of treatment. Dropless periocular drug delivery during cataract surgery may improve the outcomes and cost-effectiveness of cataract surgery, and may alleviate the burden on homecare organizations.
Timeline
- Start
- 2021-10-13
- Primary completion
- 2024-08-13
- Completion
- 2024-08-13
Outcome
Outcome not reported
Stopped: “Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bromfenac | Other / unclassified | 0.09 % | Topical |
| Comparator | Dexamethasone | Small molecule | 0.1 % | Topical |
| Comparator | Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution | Unknown | 0.023 mg/ml | Other |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 10 mg | Other |